Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 2a Randomized, Double-blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Effects Of PF-05175157 On Moderate To Severe Acne Vulgaris In Adult Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02100527
• Other study ID #: B1731019
• Status: Withdrawn
• Phase: Phase 2
• First received: March 27, 2014
• Last updated: May 12, 2014
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157 administered for 6 weeks in subjects with moderate to severe acne vulgaris.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males 18 years or older diagnosed with moderate to severe acne vulgaris who are otherwise healthy.

• Normal spirometry at screening (FEV1 and FVC (Forced Vital Capacity)at least 80% predicted).

• Minimum of 20 inflammatory lesions on the face.

• Willing to discontinue other acne treatments prior to and during the study period through follow-up.

Exclusion Criteria:

• Subjects with active nodulocystic acne.

• Subjects unwilling to comply with lifestyle guidelines, commit to study visits, and perform study procedures.

• History of dry eye or other known disease that affects the sclera or cornea.

• History of pulmonary disease or inability to adequately perform testing.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• PF-05175157
200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks
• Placebo
placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests	Weeks 2, 4, and 6	Yes
Secondary	Sebum measurements	Change from baseline in amount and rate of sebum excretion	Weeks 2, 4, and 6	No
Secondary	Pharmacokinetics of PF-05175157	Plasma concentrations	Weeks 2, 4, and 6	No

External Links

•   To obtain contact information for a study center near you, click here.